Neoadjuvant Ipilimumab in Prostate Cancer

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT01194271
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Leuprolide Acetate — DRUG
    22.5 mg administered as a single intramuscular 3 month depot.
  • Ipilimumab — DRUG
    10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.
  • Radical Prostatectomy — PROCEDURE
    Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.

Study Details

The goal of this clinical research study is to learn how ipilimumab in combination with Lupron (leuprolide acetate) affects the body's own defense (immune) system before having surgery to remove prostate cancer. The safety of the drug combination will also be studied.

Key Dates

Start date
Sep 30, 2010
Status verified
Sep 2023
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Neoadjuvant Ipilimumab
    Leuprolide Acetate 22.5 mg administered as a single intramuscular 3 month depot + Ipilimumab 10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy + Radical Prostatectomy Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.

Primary Outcome Measure

Immunologic Response: Number of Participants With Immune Response [ Time Frame: Baseline to Week 8 ]

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
University of Texas MD Anderson Cancer Center· Houston, TX

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